Clinical Evaluation of Advanced Platelet Rich Fibrin With (DFDBA) Compared to Collagen Membrane With (DFDBA) in Treatment of Non-contained Intraosseous Defects in Stage III Periodontitis Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in clinical attachment level (CAL)
研究概览
简要总结
to assess the effectiveness of advanced PRF in combination of Demineralized freeze-dried bone allograft (DFDBA) as compared to collagen membrane in combination with Demineralized freeze-dried bone allograft (DFDBA) treatment of non-contained periodontal intraosseous defects in stage III periodontitis patients.
详细描述
Treatment of intraosseous periodontal defects represents a clinical challenge; these defects have been detected through clinical and radiographic examination in 18- 51 % of patients with periodontitis. They are often associated with persistent deep pockets and bleeding following conventional periodontal treatment. Complex regenerative periodontal therapy is advocated for management of these defects. The outcomes of regenerative periodontal therapy are positively correlated with the morphology of osseous defects. Non-contained defects are prevalent clinically and have been reported to have a low regenerative potential.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the type of intervention only the outcome assessor and the statistician will be blinded.
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stage III periodontitis patient having at least one tooth with one wall or combined1- to 2-wall intraosseous defect ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
- •Defect not extending to a root furcation area
- •Vital teeth
- •Non-smokers.
- •No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
- •No periodontal therapy carried out in the past 6 months.
- •Able to sign an informed consent form.
- •Patients age between 25 and 50 years old.
- •Patients who are cooperative, motivated, and hygiene conscious.
- •Systemically free according to Cornell Medical Index
排除标准
- •Pregnancy or breast feeding
- •The presence of an orthodontic appliance
- •Teeth mobility greater than grade I
研究组 & 干预措施
Advanced- platelets rich fibrin with DFDBA
In A-PRF assigned group, one PRF will be cut into small pieces and added to the Demineralized freeze-dried bone allograft (DFDBA) in a ratio of 1:1 and the mixture is applied into the intraosseous defect, and the other will be used to prepare the membrane to cover the defect as a barrier. The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures.
干预措施: Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA) (Procedure)
Collagen membrane and DFDBA
After debridement and intraoperative recordings, in the control group, Demineralized freeze-dried bone allograft (DFDBA) will be applied to the bone defect without overfilling and is protected by a collagen membrane, then interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.
干预措施: Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA) (Procedure)
结局指标
主要结局
Change in clinical attachment level (CAL)
时间窗: CAL will be measured at base line, 3, 6, 9, 12 months postoperative
CAL will be measured from the CEJ to the bottom of the gingival sulcus/periodontal pocket using UNC periodontal probe at six sites per tooth.
次要结局
- Gingival Recession Depth (RD)(RD will be measured at base line, 3, 6, 9, 12 months postoperative)
- Radiographic defect fill (IBD)(IBD will be measured at base line, 3, 6, 9, 12 months postoperative)
- Post-surgical patient satisfaction(After 12 months postoperative)
- Pobing Depth (PD)(PD will be measured at base line, 3, 6, 9, 12 months postoperative)
研究者
Najeeb Mohammed Mahyoub Ahmed
Principal Investigator
Cairo University